Failed studies, alternate designs [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2013-12-26 15:10 (3852 d 01:52 ago) – Posting: # 12112
Views: 7,237

Hi kvgreddy06,

THX for reminding us!

❝ […] is going to be comes in effect from 02nd January 2014.


Where do you get this information from? It’s a draft and 20 comments have been submitted so far (although none are posted at regulations.gov yet).

Understandably the FDA wants to decrease its workload refusing failed and alternate designs without previous correspondence*.

line 640: FDA will refuse to receive an ANDA if only a failed study is submitted.
644–647: Submitting a non-recommended in vivo study without adequate justification will result in FDA refusing to receive an ANDA. We encourage applicants to consult the BE recommendations webpage for product-specific study information or to contact the Division of Bioequivalence via Control Correspondence for further guidance if needed.




Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,099 posts in 4,857 threads, 1,646 registered users;
58 visitors (0 registered, 58 guests [including 10 identified bots]).
Forum time: 18:03 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5